NCT00269360

Brief Summary

The purpose of this study is to compare three treatments for neck pain: 1) rehabilitative exercise, 2) chiropractic spinal manipulation combined with rehabilitative exercise, and 3) self-care education.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
270

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2001

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2001

Completed
3.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2005

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 21, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 23, 2005

Completed
Last Updated

November 20, 2007

Status Verified

November 1, 2007

First QC Date

December 21, 2005

Last Update Submit

November 19, 2007

Conditions

Neck Pain

Keywords

ChiropracticManual TherapiesExerciseRandomizedClinical TrialNeck Pain

Outcome Measures

Primary Outcomes (1)

  • Patient rated pain(0-10 scale,11 box)

    short term = 12 weeks; long term = 52 weeks

Secondary Outcomes (14)

  • Neck Disability Index (NDI)at baseline, weeks 4,12,26,52

    short term = 12 weeks; long term = 52 weeks

  • General health status at baseline, weeks 4,12,26,52

    short term = 12 weeks; long term = 52 weeks

  • Improvement (Global Change)at baseline, weeks 4,12,26,52

    short term = 12 weeks; long term = 52 weeks

  • Disability Days at baseline, weeks 4,12,26,52

    short term = 12 weeks; long term = 52 weeks

  • Bothersomeness of Symptoms at baseline, weeks 4,12,26,52

    short term = 12 weeks; long term = 52 weeks

  • +9 more secondary outcomes

Study Arms (3)

1

EXPERIMENTAL
Procedure: Chiropractic + Supervised Rehabilitative Exercise

2

EXPERIMENTAL
Procedure: Supervised Rehabilitative Exercise

3

ACTIVE COMPARATOR
Behavioral: Self-care education

Interventions

Chiropractic + Supervised Rehabilitative ExercisePROCEDURE

Chiropractic care will include manual spinal manipulation, with light soft tissue massage as indicated to facilitate the spinal manipulative therapy. The spinal levels treated will be determined by the individual chiropractors by static and/or motion palpation. Patients will attend 20, 1 hour sessions of rehabilitative exercises for the neck and upper body. Each session will begin with a 10-minute aerobic warm-up of the upper body and five minutes of light stretching to prepare for the strengthening exercises.

1
Supervised Rehabilitative ExercisePROCEDURE

Patients will attend 20, 1 hour sessions of rehabilitative exercises for the neck and upper body. Each session will begin with a 10-minute aerobic warm-up of the upper body and five minutes of light stretching to prepare for the strengthening exercises.

2
Self-care educationBEHAVIORAL

Self-care education will be provided by the therapist trained in the study protocol. Two, one-hour sessions will be given regarding self-care measures and ergonomics relative to work and activities of daily living. These will include postural instructions and practical demonstrations of proper body mechanics performed with patient participation.

3

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chronic mechanical neck pain (defined as current episode \> 12 weeks' duration).
  • Quebec Task Force classifications 1, 2, 3 and 4. This includes patients with neck pain, stiffness or tenderness, with or without musculoskeletal and neurological signs.

You may not qualify if:

  • Previous cervical spine surgery
  • Neck pain referred from local joint lesions of the lower extremities or from visceral diseases
  • Progressive neurological deficits due to nerve root or spinal cord compression
  • Existing cardiac disease requiring medical treatment
  • Blood clotting disorders
  • Diffuse idiopathic hyperostosis
  • Infectious and non-infectious inflammatory or destructive tissue changes of the cervical spine
  • Presence of significant infectious disease, or other severe disabling health problems
  • Substance abuse
  • Ongoing treatment for neck pain by other health care providers
  • Pregnant or nursing women
  • Average neck pain score of less than 30 percentage points
  • Pending or current litigation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wolfe-Harris Center for Clinical Studies

Bloomington, Minnesota, 55431, United States

Location

Related Publications (1)

  • Evans R, Bronfort G, Schulz C, Maiers M, Bracha Y, Svendsen K, Grimm R, Garvey T, Transfeldt E. Supervised exercise with and without spinal manipulation performs similarly and better than home exercise for chronic neck pain: a randomized controlled trial. Spine (Phila Pa 1976). 2012 May 15;37(11):903-14. doi: 10.1097/BRS.0b013e31823b3bdf.

    PMID: 22024905DERIVED

Related Links

MeSH Terms

Conditions

Neck PainMotor Activity

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Gert Bronfort, DC, PhD

    Northwestern Health Sciences University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 21, 2005

First Posted

December 23, 2005

Study Start

March 1, 2001

Study Completion

February 1, 2005

Last Updated

November 20, 2007

Record last verified: 2007-11

Locations

US(1)